References (all domains)

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Evaluations of pediatric research

  1. Campbell H, Surry SAM, Royle EM. A review of randomised controlled trials published in Archives of Disease in Childhood from 1982-96. Arch Dis Child 1998; 79:192-197. [PubMed]
  2. Cheng K, Smyth RL, Motley J, et al. Randomized controlled trials in cystic fibrosis (1966-1997) categorized by time, design, and intervention. Pediatr Pulmonol 2000; 29:1-7. [PubMed]
  3. Thakur A, Wang EC, Chiu TT, et al. Methodology standards associated with quality reporting in clinical studies in pediatric surgery journals. J Pediatr Surg 2001; 36:1160-1164. [PubMed]
  4. Moss RL, Henry MCW, Dimmitt RA, et al. The role of prospective randomized clinical trials in pediatric surgery: state of the art? J Pediatr Surg 2001;36:1182-1186. [PubMed]
  5. Moher D, Sampson M, Campbell K, et al. Assessing the quality of reports of randomized trials in pediatric complementary and alternative medicine. BMC Pediatr 2002; 2:2. [PubMed]
  6. Curry JI, Reeves B, Stringer MD. Randomized controlled trials in pediatric surgery: could we do better? J Pediatr Surg 2003; 38:556-559. [PubMed]
  7. Welk B, Afshar K, MacNeily AE. Randomized controlled trials in pediatric urology: room for improvement. J Urol 2006;176:306-310. [PubMed]
  8. Briggs TA, Bryant M, Smyth RL. Controlled trials in cystic fibrosis - are we doing better? J Cyst Fibros 2006; 5:3-8. [PubMed]
  9. Anttila H, Malmivaara A, Kunz R, et al. Quality of reporting of randomized, controlled trials in cerebral palsy. Pediatrics. 2006; 117:2222-2230. [PubMed]
  10. Dulai SK, Slobogean BLT, Beauchamp RD, et al. A quality assessment of randomized clinical trials in pediatric orthopaedics. J Pediatr Orthop 2007;27:573-581. [PubMed]
  11. Abrahamyan L, Johnson SR, Beyene J, et al. Quality of randomized clinical trials in juvenile idiopathic arthritis. Rheumatology 2008; 47:640-645. [PubMed]
  12. Brooks RJ, Higgins GY, Webster AC. Systematic review of randomized controlled trial quality in pediatric kidney transplantation. Pediatr Nephrol 2010; 25:2383-2392. [PubMed]
  13. Uman LS, Chambers CT, McGrath PJ, et al. Assessing the quality of randomized controlled trials examining psychological interventions for pediatric procedural pain: recommendations for quality improvement. J Pediatr Psychol 2010;35:693-703. [PubMed]
  14. Nor Aripin KNB, Choonara I, Sammons HM. A systematic review of paediatric randomised controlled drug trials published in 2007. Arch Dis Child 2010;95:469-473. [PubMed]
  15. Thomson D, Hartling L, Cohen E, et al. Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006. PLoS One 2010;5:e13106. [PubMed]
  16. DeMauro SB, Giaccone A, Kirpalani H, et al. Quality of reporting of neonatal and infant trials in high-impact journals. Pediatrics 2011;128:e639. [PubMed]
  17. Hartling L, Ospina M, Liang Y, et al. Risk of bias versus quality assessment of randomised controlled trials: cross sectional study. BMJ 2009;339:b4012. [PubMed]
  18. Crocetti MT, Amin DD, Scherer R. Assessment of risk of bias among pediatric randomized controlled trials. Pediatrics 2010;126:298-305. [PubMed]
  19. Hamm MP, Hartling L, Milne A, et al. A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007. BMC Pediatrics 2010;10:96. [PubMed]
  20. Walleser S, Hill SR, Bero LA. Characteristics and quality of reporting of cluster randomized trials in children: reporting needs improvement. J Clin Epidemiol 2011; 64:1331-1340. [PubMed]
  21. Duffett M, Choong K, Hartling L, et al. Randomized controlled trials in pediatric critical care: a scoping review. Critical Care 2013; 17:R256. [PubMed]

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Methodological papers

  1. Altman DG. The scandal of poor medical research. BMJ 1994;308:283-284. [PubMed]
  2. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet 2009;374:86-89. [PubMed]
  3. Hopewell S, Dutton S, Yu LM, et al. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ 2010;340:c723. [PubMed]

Sequence generation

  1. Altman DG, Bland JM. How to randomise. BMJ 1999; 319:703-704. [PubMed]
  2. Als-Nielsen B, Gluud LL, Gluud C. Methodological quality and treatment effects in randomised trials: a review of six empirical studies. 12th Cochrane Colloquium 2004;Oct 2-6 (Ottawa, Ontario, Canada). [Cochrane]

Allocation concealment

  1. Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408-412. [PubMed]
  2. Als-Nielsen B, Gluud LL, Gluud C. Methodological quality and treatment effects in randomised trials: a review of six empirical studies. 12th Cochrane Colloquium 2004;Oct 2-6 (Ottawa, Ontario, Canada). [Cochrane]
  3. Pildal J, Hrobjartsson A, Jorgensen KJ, et al. Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials. Int J Epidemiol 2007;36:847-857. [PubMed]

Blinding

  1. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996;17:1-12. [PubMed]
  2. Boutron I, Estellat C, Guittet L, et al. Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review. PLoS Med 2006; 3:e425. [PubMed]
  3. Rheims S, Cucherat M, Arzimanoglou A, et al. Greater response to placebo in children than in adults: a systematic review and meta-analysis in drug-resistant partial epilepsy. PLoS Med 2008;5:e166. [PubMed]
  4. Karanicolas PJ, Farrokhyar F, Bhandari M. Practical tips for surgical research: blinding: who, what, when, why, how? Can J Surg 2010;53:345-348. [PubMed]
  5. Friedberg JP, Lipsitz SR, Natarajan S. Challenges and recommendations for blinding in behavioral interventions illustrated using a case study of a behavioral intervention to lower blood pressure. Patient Educ Couns 2010;78:5-11. [PubMed]

Incomplete outcome data

  1. Abraha I, Duca PG, Montedori A. Empirical evidence of bias: modified intention to treat analysis of randomised trials affects estimates of intervention efficacy. Z Evid Fortbild Qual Gesundhwes 2008;102(Suppl VI),9. [Cochrane]
  2. Bell ML, Kenward MG, Fairclough DL, Horton NJ. Differential dropout and bias in randomised controlled trials: when it matters and when it may not. BMJ 2013; 346:e8668. [PubMed]

Selective outcome reporting

  1. Hutton JL, Williamson PR. Bias in meta-analysis due to outcome variable selection within studies. Journal of the Royal Statistical Society Series C 2000;49:359-370.
  2. Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA 2001; 285:437-443. [PubMed]
  3. Chan AW, Hróbjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004;291:2457-2465. [PubMed]
  4. Chan AW, Krleza-Jeric K, Schmid I, et al. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ 2004;171:735-740. [PubMed]
  5. Papanikolaou PN, Ioannidis JP. Availability of large-scale evidence on specific harms from systematic reviews of randomized trials. Am J Med 2004; 117:582-589. [PubMed]
  6. Von Elm E, Rollin A, Blumle A, et al. Selective reporting of outcomes of drug trials? Comparison of study protocols and published articles. 14th Cochrane Colloquium 2006;Oct 23-26 (Dublin, Ireland). [Cochrane]
  7. Dwan K, Altman DG, Amaiz JA, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One 2008;3:e3081. [PubMed]
  8. Mathieu S, Boutron I, Moher D, et al. Comparison of registered and published primary outcomes in randomised controlled trials. JAMA 2009;302:977-984. [PubMed]
  9. Ioannidis JP. Adverse events in randomized trials: neglected, restricted, distorted, and silenced. Arch Intern Med 2009; 169:1737-1739. [PubMed]

Other sources of bias

  1. Lexchin J, Bero LA, Djulbegovic B, et al. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003;326:1167-1170. [PubMed]
  2. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003;298:454-465. [PubMed]
  3. Montori VM, Devereaux PJ, Adhikari NK, et al. Randomized trials stopped early for benefit: a systematic review. JAMA 2005;294:2203-2209. [PubMed]
  4. Bassler D, Ferreira-Gonzalez I, Briel M, et al. Systematic reviewers neglect bias that results from trials stopped early for benefit. J Clin Epidemiol 2007;60:869-873. [PubMed]
  5. Sismondo S. Pharmaceutical company funding and its consequences: a qualitative systematic review. Contemp Clin Trials 2008;29:109-113. [PubMed]

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Other important references


Methods

  1. Higgins JPT, Altman DG, Sterne JAC. Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane handbook for systematic reviews of interventions version 5.1.0. Cochrane Collaboration; 2011. [Cochrane Handbook]
  2. Juni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ 2001; 323:42-46. [PubMed]
  3. DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA 2004;292:1363-1364. [PubMed]
  4. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med 2010;7:e1000251. [PubMed]
  5. Djulbegovic B, Kumar A, Glasziou PP, Perera R, Reljic T, Dent L, Raftery J, Johansen M, Di Tanna GL, Miladinovic B, Soares HP, Vist GE, Chalmers I. New treatments compared to established treatments in randomized trials. Cochrane Database Syst Rev 2012; 10:MR000024. doi: 10.1002/14651858.MR000024.pub3. [PubMed]
  6. Savovic J, Jones HE, Altman DG, et al. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med 2012; 157:429-438. [PubMed]
  7. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013: new guidance for content of clinical trial protocols. Lancet 2013; 381:91-92. [PubMed]
  8. Chan AW, Tetzlaff JM, Gotzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013; 346:e7586. [PubMed]
  9. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Ann Intern Med 2013; doi:10.7326/0003-4819-158-3-201302050-00583 [Epub ahead of print]. [PubMed]

Pediatrics

  1. Caldwell PHY, Murphy SB, Butow PN, et al. Clinical trials in children. Lancet 2004;364:803-811. [PubMed]
  2. Cohen E, Uleryk E, Jasuja M, et al. An absence of pediatric randomized controlled trials in general medical journals, 1985-2004. J Clin Epidemiol 2007;60:118-123. [PubMed]
  3. Klassen TP, Hartling L, Craig JC, et al. Children are not just small adults: the urgent need for high-quality trial evidence in children. PLoS Med 2008;5:e172. [PubMed]
  4. Martinez-Castaldi C, Silverstein M, Bauchner H. Child versus adult research: the gap in high-quality study design. Pediatrics 2008;122:52-57. [PubMed]
  5. Pandolfini C, Bonati M. Children's presence in research: a review of online registers. Eur J Clin Pharmacol 2009;65:873-880. [PubMed]
  6. Hartling L, Hamm MP, Fernandes RM, et al. Quantifying bias in randomized controlled trials in child health: a meta-epidemiological study. PLoS ONE 2014; 9:e88008. [PubMed]

StaR Child Health

  1. Klassen TP, Hartling L, Hamm M, et al. StaR Child Health: an initiative for RCTs in children. Lancet 2009;374:1310-1312. [PubMed]
  2. Hartling L, Wittmeier KDM, van der Lee JH, et al. StaR Child Health: developing evidence-based guidance for the design, conduct, and reporting of pediatric trials. Clin Pharmacol Ther 2011;90:727-731. [PubMed]
  3. Caldwell PHY, Dans L, de Vries MC, et al. Standard 1: consent and recruitment. Pediatrics 2012; Suppl 3:S118-S123. [PubMed]
  4. Hartling L, Hamm M, Klassen T, et al. Standard 2: containing risk of bias. Pediatrics 2012; Suppl 3:S124-131. [PubMed]
  5. Ellenberg S, Fernandes RM, Saloojee H, et al. Standard 3: data monitoring committees. Pediatrics 2012; Suppl 3:S132-137. [PubMed]
  6. van der Tweel I, Askie L, Vandermeer B, et al. Standard 4: determining adequate sample sizes. Pediatrics 2012; Suppl 3:S138-145. [PubMed]
  7. Sinha IP, Altman DG, Beresford MW, et al. Standard 5: selection, measurement, and reporting of outcomes in clinical trials in children. Pediatrics; Suppl 3:S146-152. [PubMed]
  8. Williams K, Thomson D, Seto I, et al. Standard 6: age groups for pediatric trials. Pediatrics 2012; Suppl 3:S153-160. [PubMed]
  9. Contopoulos-Ioannidis DG, Seto I, Hamm MP, et al. Empirical evaluation of age groups and age-subgroup analyses in pediatric randomized trials and pediatric meta-analyses. Pediatrics 2012; Suppl 3;S161-S184. [PubMed]


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